Vacuum assisted lancing system with elective vacuum release  and method for blood extraction with minimal pain

ABSTRACT

A vacuum assisted lancing system for blood extraction can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can include means for selectively commencing dissipation of the vacuum and a fixed or adjustable depth controller. A method of manipulating a surface for blood extraction can include coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 14/184,307 filed onFeb. 19, 2014, which is a continuation of U.S. Ser. No. 13/367,953 filedon Feb. 7, 2012, which is a continuation-in-part of U.S. Ser. Nos.12/689,570; 12/689,608; 12/689,618; 12/689,641; and 12/689,657; each ofwhich was filed on Jan. 19, 2010.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO APPENDIX

Not applicable.

BACKGROUND OF THE INVENTION Field of the Invention

The invention disclosed and taught herein relates generally to bloodextraction devices and methods. More specifically, the invention relatesto vacuum assisted lancing devices and methods useful for extracting aquantity of blood for sampling or testing.

Description of the Related Art

There are many medical reasons where a small quantity of blood needs tobe drawn from a human. Determining blood glucose levels for diagnosisand treatment of diabetes is one of the most common applications whereaccess to blood is required. Diabetes has become a significant healthrisk in the United States and other parts of the world. The rise indiabetes has caused alarm in the medical community. Major companies,research institutions, and the consuming public are collectivelyspending significant resources for the prevention, testing, andtreatment of diabetes. A person with diabetes is generally required totest their blood several times a day for glucose levels and takecorrective action if needed. Failure to test and take corrective actionwhen necessary can result in injury, both long and short termdegradation of the human body's functions, and in some cases death.

Currently, the market provides an assortment of devices that lance theskin producing a wound or other opening from which blood can beextracted. However, most require testing on an area of a user's skinthat has a high concentration of blood vessels near the surface of theskin so that the lance can produce an acceptable quantity of blood. Themost common area for testing is the finger tips, although the toes havealso been used. However, these heavily vasculated areas of the humanbody are typically highly sensitive, having a rich supply of nerveendings. As a result, blood rich areas, such as the finger tips, oftenare more pain sensitive than other less vasculated areas. Thus, the veryareas that are ideally suited for extracting blood for testing are themost sensitive to pain.

For those individuals who are required to test themselves, the frequenttesting can have negative effects on their emotional health, physicalhealth, and even personalities. At the least, in an effort to avoidpain, they are motivated to not test as often as required by theirphysician. A loss of frequency and continuity in the testing can lead tophysical and emotional complications, or a significant loss of accuracyin determining proper dietary corrections and medicine regiments. Healthcare practitioners may also be required to lance a patient's skin toextract blood for testing, which is typically done in the fingers. Insome situations, however, the fingers and toes may not be available fortesting, such as when these areas of the patient's body are bandaged orinjured, and an alternative testing site on the patient's body may berequired.

Some blood extraction devices simply lance the skin and the patientmanually squeezes the area to produce the required quantity of blood.Other blood extraction devices seek to use a vacuum to enhance the bloodrecovery from the lancing. However, in surveying the market of suchdevices, the inventor has realized that the vacuum assisted devices areeither not portable with mechanized vacuum pumps, which cansignificantly diminish their value for mobile patients, or requireunwanted maintenance, such as replacement of batteries, which are notalways available. Further, many of such devices fail to adequatelyproduce a desirable quantity of blood from portions of the skin otherthan the fingers and toes. Newer devices house multiple lances in thesame holder, and with each use a new lance is automatically selected andused such that the patient never uses the same lance twice. Many, if notall, of these devices, including the ones that apply a vacuum, have beenunsuccessful in reliably extracting sufficient quantities of blood fromareas of the skin less painful than the fingers and toes. Reduction orelimination of pain has been shown to appreciably encourage the patientto follow the testing procedure prescribed by an attending physician.

While each of these devices may have certain limited applications, thereremains a need to provide a simplified and improved vacuum assistedlancing device that can be routinely used at various places on the skinand still extract a sufficient quantity of blood for the required test.

BRIEF SUMMARY OF THE INVENTION

A vacuum assisted lancing system for blood extraction can include atubular body having a vacuum chamber, a lancing mechanism configured toremovably couple with a lance, a vacuum mechanism including a pistonslideably coupled within the body, a release mechanism for selectivelyholding the vacuum mechanism in an energized state, and an opening forallowing fluid communication between the vacuum chamber and anatmosphere surrounding the vacuum chamber. The system can include meansfor selectively commencing dissipation of the vacuum. A method ofmanipulating a surface for blood extraction can include coupling thelancing system to the surface, blocking the opening, creating a vacuum,moving the lance coupler from a first position distal from the surfaceto a second position proximal to the surface, maintaining the vacuum fora period of time, and commencing dissipation of the vacuum by unblockingthe opening.

A vacuum assisted lancing system for blood extraction can include a bodyhaving a central longitudinal axis, a lancing end and a free end, alancing mechanism coupled with the body and adapted to removably couplewith a lance, a vacuum mechanism coupled with the body and including apiston slideably coupled with the body so that a vacuum chamber can beformed between the piston and the lancing end of the body, a releasemechanism adapted to selectively hold the vacuum mechanism in anenergized state, and an opening through the body that can allow fluidcommunication between the vacuum chamber and an atmosphere surroundingthe vacuum chamber. The opening through the body can be adapted to besealingly engaged by a user so that the user can selectively block andunblock the opening.

The release mechanism can include a release, and the opening can bedisposed in the release. The release can have an activated position, andthe opening can be adapted to be at least partially blocked when therelease is in the activated position. The system can include a valvecoupled to the opening, and can include a tubular lance guide removablycoupled to the body and adapted to sealingly engage a surface to belanced. The lance guide can have a transparent viewing area for viewingthe surface. The system can include a depth controller coupled to thebody and adapted to sealingly engage a surface to be lanced. The depthcontroller can be fixed or adjustable and can include a spacer having avariable thickness. The system can include a lance coupled to thelancing mechanism.

A vacuum assisted lancing system for blood extraction can include a bodyhaving a first end adapted to sealingly engage a surface to be lanced, alongitudinally opposite second end, and a vacuum chamber between thefirst and second ends, means for creating a vacuum in the vacuum chamberand acting on the surface, means for disposing a lance in contact withthe surface while the vacuum is acting on the surface, and means forselectively commencing dissipation of the vacuum after the vacuum hasacted on the surface for a period of time. The means for selectivelycommencing dissipation of the vacuum can include an opening through thebody for allowing fluid communication between the vacuum chamber and anatmosphere surrounding the vacuum chamber. The means for creating avacuum can include a release coupled to the body, and the openingthrough the body can be disposed through the release. The system caninclude means for simultaneously initiating creation of the vacuum andat least partially blocking the opening. The system can include meansfor dissipating the vacuum at a controlled rate. The system can includea lance coupled to the means for disposing a lance in contact with thesurface.

A method of manipulating a surface for blood extraction can includecoupling a lancing system to the surface, blocking an opening,activating the lancing system, thereby creating a vacuum, subjecting thesurface to the vacuum, and moving a lance coupler from a first positiondistal from the surface to a second position proximal to the surface,maintaining the vacuum for a period of time, and commencing dissipationof the vacuum. Commencing dissipation of the vacuum can includeunblocking the opening and allowing the surface to fluidicly communicatewith an atmosphere surrounding the lancing system while the lancingsystem is coupled to the surface.

The lancing system can include a release coupled with the opening, andthe blocking and activating steps can be accomplished simultaneously byengaging and holding the release. Commencing dissipation of the vacuumcan include disengaging the release. Blocking the opening can includesealingly engaging the opening with a finger or other body, andunblocking the opening can include disengaging the opening and thefinger or other body. The lancing system can include a lance removablycoupled to a lance coupler, and the method can include lancing thesurface. The method can include maintaining the vacuum for a period oftime after the surface has been lanced, and can include verifying thatan amount of blood has been extracted prior to commencing dissipation ofthe vacuum.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an isometric schematic view of one of many embodiments of avacuum lance system according to the disclosure.

FIG. 2 is an isometric assembly schematic view of the vacuum lancesystem of FIG. 1.

FIG. 3A is a cross-sectional schematic view of another of manyembodiments of a vacuum lance system having an indicator according tothe disclosure.

FIG. 3B is a cross-sectional schematic view of the indicator of FIG. 3Ain a viewing window.

FIG. 4 is a cross-sectional schematic view of one of many embodiments ofa lancing mechanism according to the disclosure.

FIG. 5A is an illustration of one of many embodiments of a vacuum lancesystem in a cocked position according to the disclosure.

FIGS. 5B, 5C and 5D are illustrations of the system of FIG. 5A in threerespective positions during lancing.

FIG. 5E is an illustration of the system of FIG. 5A in an uncockedposition.

FIG. 5F is an illustration of the system of FIG. 5A manipulating asurface during lancing.

FIG. 5G is an illustration of the system of FIG. 5A vibrating a surfaceduring lancing.

FIG. 5H is a graph illustrating one example of the vacuum magnitudeversus the time over which lancing can occur during a vacuum cycleaccording to the disclosure.

FIG. 6 is a front isometric schematic view of one of many embodiments ofa vacuum lance system having a depth controller according to thedisclosure.

FIG. 7A is a cross-sectional schematic view of the system of FIG. 6.

FIG. 7B is a cross-sectional schematic view of the system of FIG. 6 witha base contacting a spacer.

FIG. 7C is a cross-sectional schematic view of the system of FIG. 6during blood extraction.

FIG. 8A is an illustration of one of many embodiments of a vacuum lancesystem having a lance tool according to the disclosure.

FIG. 8B is an illustration of a lance being inserted into a lancecoupler with the lance tool of FIG. 8A.

FIG. 8C is an illustration of a lance being coupled to the lance couplerwith the lance tool of FIG. 8A.

FIG. 8D is an illustration of a lance being removed from the lancecoupler with the lance tool of FIG. 8A.

FIG. 9 is a cross-sectional schematic view of one of many embodiments ofa vacuum lance system having an external vacuum indicator according tothe disclosure.

FIG. 10 is a cross-sectional schematic view of one of many embodimentsof a vacuum lance system having an external vacuum assembly according tothe disclosure.

FIG. 11 is an isometric schematic view of another of many embodiments ofa vacuum lance system according to the disclosure.

FIG. 12 is an isometric assembly schematic view of the vacuum lancesystem of FIG. 11.

FIG. 13A is a cross-sectional schematic view of the vacuum lance systemof FIG. 11 in a cocked position.

FIG. 13B is a cross-sectional schematic view of the vacuum lance systemof FIG. 11 in an uncocked position.

FIG. 14 is a cross-sectional schematic view of one of many embodimentsof a lancing mechanism according to the disclosure.

FIG. 14A is a cross-sectional schematic view of the release mechanism ofFIG. 14 coupled to the main shaft before activation.

FIG. 14B is a cross-sectional schematic view of the release mechanism ofFIG. 14A uncoupled from the main shaft after activation.

FIG. 14C is a schematic view of another of many embodiments of a releasemechanism in a deactivated position according to the disclosure.

FIG. 14D is a schematic view of the release mechanism of FIG. 14C in anactivated position according to the disclosure.

FIG. 14E is a schematic view of yet another of many embodiments of arelease mechanism in a deactivated position according to the disclosure.

FIG. 14F is a schematic view of the release mechanism of FIG. 14E in anactivated position according to the disclosure.

FIG. 15A is an illustration of the vacuum lance system of FIG. 11 in acocked position according to the disclosure.

FIG. 15B is an illustration of the vacuum lance system of FIG. 15A inone of many activated positions wherein the first and second portions ofthe shaft coupler are coupled according to the disclosure.

FIG. 15C is an illustration of the vacuum lance system of FIG. 15A inanother of many activated positions wherein the first and secondportions of the shaft coupler are uncoupled according to the disclosure.

FIG. 15D is an illustration of the vacuum lance system of FIG. 15A inanother of many activated positions wherein the opening in the releaseis sealed according to the disclosure.

FIG. 15E is an illustration of the vacuum lance system of FIG. 15A inanother of many activated positions wherein the opening in the releaseis not sealed according to the disclosure.

FIG. 15F is an illustration of the system of FIG. 15A in an uncockedposition.

FIG. 15G is a graph illustrating another example of vacuum magnitudeversus a time over which lancing can occur during a vacuum cycleaccording to the disclosure.

FIG. 16 is an isometric schematic view of yet another of manyembodiments of a vacuum lance system according to the disclosure.

FIG. 17 is an isometric assembly schematic view of the vacuum lancesystem of FIG. 16.

FIG. 18 is a schematic view of one of many embodiments of a vacuum lancesystem having an adjustable depth controller in a first positionaccording to the disclosure.

FIG. 19 is a schematic view of the system of FIG. 18 with the adjustabledepth controller in a second position.

DETAILED DESCRIPTION OF THE INVENTION

The Figures described above and the written description of specificstructures and functions below are not presented to limit the scope ofwhat Applicant has invented or the scope of the appended claims. Rather,the Figures and written description are provided to teach any personskilled in the art to make and use the invention for which patentprotection is sought. Those skilled in the art will appreciate that notall features of a commercial embodiment of the invention are describedor shown for the sake of clarity and understanding. Persons of skill inthis art will also appreciate that the development of an actualcommercial embodiment incorporating aspects of the present inventionwill require numerous implementation-specific decisions to achieve thedeveloper's ultimate goal for the commercial embodiment. Suchimplementation-specific decisions may include, and likely are notlimited to, compliance with system-related, business-related,government-related and other constraints, which may vary by specificimplementation, location, and from time to time. While a developer'sefforts might be complex and time-consuming in an absolute sense, suchefforts would be, nevertheless, a routine undertaking for those ofordinary skill in this art having benefit of this disclosure. It must beunderstood that the invention disclosed and taught herein is susceptibleto numerous and various modifications and alternative forms. Lastly, theuse of a singular term, such as, but not limited to, “a,” is notintended as limiting of the number of items. Also, the use of relationalterms, such as, but not limited to, “top,” “bottom,” “left,” “right,”“upper,” “lower,” “down,” “up,” “side,” and the like are used in thewritten description for clarity in specific reference to the Figures andare not intended to limit the scope of the invention or the appendedclaims. When referring generally to such elements, the number withoutthe letter is used. Further, such designations do not limit the numberof elements that can be used for that function. The terms “couple,”“coupled,” “coupling,” “coupler,” and like terms are used broadly hereinand can include any method or device for securing, binding, bonding,fastening, attaching, joining, inserting therein, forming thereon ortherein, communicating, or otherwise associating, for example,mechanically, magnetically, electrically, chemically, operably, directlyor indirectly with intermediate elements, one or more pieces of memberstogether and can further include without limitation integrally formingone functional member with another in a unity fashion. The coupling canoccur in any direction, including rotationally.

This disclosure provides a vacuum assisted lancing system and methodthat can be easily used at a wide variety of places on a human oranimal, even in places with less sensitivity, such as the stomach,sides, arms and legs. The system can be used with one hand and is easilyportable. The system can minimize pain due to its ability to operate onunconventional areas on a user, and in at least one embodiment minimizespain due to vibration during lancing. The term “user” and like terms areused broadly herein and include, without limitation, a person who usesthe present invention on his/her self, or a person (or animal) for whomanother person uses the present invention to lance the person (oranimal). The system's vibration can at least partially mask any painfrom a patient during lancing. Further, the lance itself can be easilyreplaced from a position external to the system with simple insertion.Not requiring batteries, nor containing any form of motor, the system isvirtually maintenance free, other than replacement of the lance afteruse and occasional common cleaning. The system can be easily carried tobe readily available wherever the user needs to take a blood sample.Integration of this system into the common mainstream method of bloodglucose measurement can be significantly assisted because the systemdraws from the same pool of body blood as other devices. Therefore,special glucose measuring instruments and supplies may not be required,and blood measurement procedures may not have to be altered from thosecurrently in practice.

FIG. 1 is an isometric schematic view of one of many embodiments ofvacuum lance system 100 according to the disclosure. FIG. 2 is anisometric assembly schematic view of the vacuum lance system of FIG. 1.FIG. 3A is a cross-sectional schematic view of another of manyembodiments of vacuum lance system 100 having an indicator 133 accordingto the disclosure. FIG. 3B is a cross-sectional schematic view of theindicator 133 of FIG. 3A in viewing window 135. FIG. 4 is across-sectional schematic view of one of many embodiments of lancingmechanism 118 according to the disclosure. FIGS. 1-4 will be describedin conjunction with one another. Vacuum lance system 100 can include adevice body 102, which can comprise, for example, a tubular vacuum body,for supporting one or more components for lancing. Device body 102 canhave a bottom lancing end 104 and a top free end 106, and can, but neednot, be transparent, in whole or in part. Device body 102 can be formedfrom any material, such as plastic, metal, or another material,separately or in combination, and can be any size required by aparticular application. System 100 can, but need not, include a grip103, such as a foam, rubber, plastic, or other holder, for holding thesystem. System 100 can, but need not, include a holder 131, such as abelt clip, pocket clip, loop, or other holder, for supporting thesystem, for example, when not in use.

System 100 can include one or more components for lancing (thecomponents collectively referred to herein as a lancing assembly), whichcan include one or more components for vacuuming, coupled to device body102. System 100 can include a lance guide 112, such as a tube, coupledto lancing end 104, such as for “aiming” system 100 or for contacting alancing surface, such as skin, for lancing, directly or indirectly.Lance guide 112 can be any size required by a particular application,and can advantageously include a viewing area 114 for viewing thesurface being lanced. Viewing area 114 can be a “window” coupled to thewall of lance guide 112, or as another example, lance guide 112 can betransparent, in whole or in part. Lance guide 112 can, but need not,have a seal 116, such as an annular seal coupled to its bottom end forsealing against a surface being lanced or, as another example, for atleast reducing discomfort to a user when system 100 is pressed againstan area of the user's body for lancing. Seal 116 can be, for example, arounded or contoured edge, a soft coating, such as a rubber coating, apad, a gasket, or another seal, in whole or in part. As another example,in at least one embodiment, which is but one of many, seal 116 can be asuction cup (see, e.g., FIG. 9). Seal 116 can, but need not, beflexible. For example, seal 116 can have an amount of flexibility, sothat lance system 100 does not have to be held substantiallyperpendicular to a lancing surface to assure sealing engagement with thesurface. Seal 116 can, but need not, include or be formed from, in wholeor in part, a material that has gripping properties, for example, sothat if the seal is moved or rotated while in contact with a surface,such as skin, the surface concurrently moves or rotates.

With further reference to FIGS. 1 and 2, system 100 can include alancing mechanism 118 coupled to lancing end 104, for example, to endcap 108, for supporting a lance 120 (also known as a “lancet”). Lance120 can include a lance base 120 a for supporting a lance needle 120 b.Lancing mechanism 118 can include a lancing shaft 122 slideably coupledwith end cap 108, such as along central longitudinal axis X, forcommunicating lance 120 with a surface during lancing. Lancing shaft 122can include a bottom lance coupling end 124 and a top actuating end 126,and can be any length required by a particular application, as will befurther described below. Lancing mechanism 118 can include a lancecoupler 128 coupled to lance coupling end 124 for coupling lance 120 toshaft 122, removably or otherwise. For example, lance coupler 128 can betubular and can form an interference or friction fit with lance base 120a. Lance coupler 128 can, but need not, be adjustable, such as by havinga slot or notch at least partially along its length, for example, forcoupling to lances of one or more sizes or shapes. As other examples,lance coupler 128 can include threads, screws, notches, or otherfasteners for coupling to a lance, as will be understood by one ofordinary skill in the art. Lancing mechanism 118 can include one or morebiasing devices, such as a lancing spring 130. Lancing spring 130 can becoupled to lancing shaft 122 for biasing shaft 122 in one or moredirections, temporarily, momentarily or otherwise, as will be furtherdescribed below. Lancing spring 130 can, but need not, comprise aplurality of springs, and can advantageously include two springs.

System 100 can include a vacuum mechanism 132 for creating a vacuum andcommunicating with lancing mechanism 118 or other components of system100. Vacuum mechanism 132 can include a main shaft 134 having a bottommain actuating end 136, a top main free end 138, and at least onerelease coupler 140, such as, for example, a notch or indention. Mainshaft 134 can be slideably coupled with top end cap 110, for example, sothat main actuating end 136 can be disposed inside device body 102 andmain free end 138 can be disposed outside device body 102. System 100can, but need not, include a knob 146, such as a button or cap coupledto main free end 138, for manipulating main shaft 134 or othercomponents. System 100 can include a release mechanism 142, such as afiring device, for communicating with main shaft 134, for example, forreleasably coupling with release coupler 140, a series of releasecouplers, or another portion of main shaft 134. Release mechanism 142can be any type of releasable coupler, adapted to cooperate with mainshaft 134, as will be understood by one of ordinary skill in the art.For example, release mechanism 142 can couple with main shaft 134 at oneor more positions along its length, such as with release coupler 140, aseries thereof or, for example, a notch, groove or outer surface, toreleasably hold main shaft 134 in a particular position until, forexample, release 144 is actuated, as will be further described below.Vacuum mechanism 132 can include a piston 148 coupled to main shaft 134for communicating with one or more other components of system 100 tocreate a vacuum. Piston 148 can be coupled, adjustably, fixedly orotherwise, anywhere on main shaft 134 inside of device body 102, suchas, for example, to main actuating end 136. Piston 148 can, but neednot, include one or more seals, such as one or more 0-rings 150, and cansealingly communicate with interior wall 152 of device body 102, whichcan, for example, form a vacuum chamber 154 inside device body 102between piston 148 and a surface to be lanced in communication with seal116.

System 100 can include one or more openings 156, such as an air passageor orifice, for fluid communication between vacuum chamber 154 and anatmosphere surrounding the vacuum chamber. Opening 156 can be calibratedto allow air to flow into vacuum chamber 154 at a predetermined vacuumdissipation rate, such as, for example, a vacuum dissipation rate lessthan a predetermined vacuum generation rate in vacuum chamber 154.Opening 156 can be any suitable place for communicating with a vacuum insystem 100, such as in device body 102 (see, e.g., FIG. 9), and canadvantageously, but need not, be in piston 148, separately or incombination. Each opening 156 can, but need not, be adjustable in size,which may include having an adjustable diameter or beinginterchangeable, separately or in combination. One or more openings 156can afford any rate of vacuum dissipation required by a particularapplication, such as a linear rate, non-linear rate, or another rate, inwhole or in part, separately or in combination.

Vacuum mechanism 132 can include a biasing device, such as vacuum spring158, coupled to piston 148 for biasing piston 148 in one or moredirections, such as in the upward direction. Vacuum spring 158 can, butneed not, include a compression spring disposed between bottom end cap108 and piston 148 that biases the piston away from bottom end cap 108.Alternatively, or collectively, for example, vacuum spring 158 caninclude a tension spring that biases piston 148 toward top end cap 110,such as a tension spring disposed between piston 148 and top end cap110, as will be understood by one of ordinary skill in the art havingthe benefits of this disclosure. Vacuum spring 158 can, but need not,include a plurality of springs.

System 100 can include a vacuum indicator 133 for indicating whether orto what extent a vacuum exists within vacuum chamber 154. For example,indicator 133 can indicate when a vacuum having at least a predeterminedmagnitude is present in the system or, as another example, when a vacuumbelow the predetermined magnitude can be present, including when novacuum is present. In at least one embodiment, which is but one of many,indicator 133 can be a visual indicator, such as a tab, mark, coloredmedia, notch, or other visible indicator, coupled to main shaft 134,piston 148, or another component, so that indicator 133 can visuallyindicate, such as by being visible, when no vacuum or a vacuum below apredetermined magnitude is present in the system. Indicator 133 can bevisible, for example, through a slot, window, portion of device body102, or other transparent media, which can be any size or shape. Asshown in FIGS. 3A and 3B, for example, indicator 133 may not be visible,such as being inside device body 102, while a vacuum having apredetermined magnitude can be present in the system, and can becomevisible, such as by passing through a portion of free end 106 and intoindicator window 135 when no vacuum or a vacuum below a predeterminedmagnitude is present in the system. As another example, indicator 133can be visible through at least a portion of device body 102, through anelongated window disposed longitudinally along device body 102, orthrough a combination thereof. Alternatively, indicator 133 need not bevisible through device body 102 and can be visible only when outside ofdevice body 102, in whole or in part (see, e.g., FIGS. 5A-5E). Forexample, and without limitation, indicator 133 can be a marking on shaft134 which only becomes visible outside of device body 102 (e.g., aboverelease mechanism 142) when shaft 134 has sufficiently exited free end106, so as to indicate that the vacuum has fallen below a predeterminedvalue. In at least one of many alternative embodiments, indicator 133can be an audible indicator, digital indicator, electrical indicator,electronic indicator or, as other examples, a pressure sensitiveindicator or mechanical indicator, separately or in combination.Indicator 133 can, but need not, indicate to a user when a vacuum insystem 100 during lancing is sufficiently dissipated (i.e., is ofsufficiently low magnitude) that system 100 can be removed from asurface being lanced. For example, in an application where skin is beinglanced for purposes of drawing blood, indicator 133 can indicate whensystem 100 can be removed from the skin so that the drawn blood does notsplatter, such as could happen due to an inrush of atmospheric air,e.g., if seal 116 were to be lifted off the skin with a relatively highvacuum in vacuum chamber 154.

System 100 can include a shaft coupler 160 for releasably coupling oneor more components of system 100, such as lancing shaft 122 and mainshaft 134. Shaft coupler 160 can include two or more portions thatoptionally couple with one another. For example, shaft coupler 160 caninclude a first portion 160 a coupled to lancing shaft 122, such as toactuating end 126, and a second portion 160 b coupled to main shaft 134,such as to main actuating end 136. First portion 160 a and secondportion 160 b can be adapted to releasably couple to one another whenbrought at least proximate to one another and to uncouple upon apredetermined event, for example, when a sufficient force applied toshaft coupler 160. In at least one embodiment, which is but one of many,one of portions 160 a, 160 b can be a magnet and the other portion canbe magnetic material, which can allow, for example, lancing shaft 122and main shaft 134 to remain coupled until a separation force, such as atensile force, is applied sufficient to overcome the coupling forcebetween first portion 160 a and second portion 160 b. Alternatively, orcollectively, either portion 160 a, 160 b can be a portion of one of theshafts 122, 134, such as one of the actuating ends 126, 136, or, asanother example, second portion 160 b can be coupled to, includingformed integrally with, piston 148. In at least one other embodiment,which is but one of many, first and second portions of shaft coupler 160can include hook and loop material, mechanical fasteners, ball and jointunions, sticky material, or other couplers, as required by a particularapplication. In at least one embodiment, which is but one of many, asufficient separation force can be any force less than a force generatedby the vacuum spring 158 (see, e.g., FIG. 2).

With reference to FIG. 4, lancing mechanism 118 can, but need not,include bottom end cap 108. Alternatively, lancing mechanism 118 can beseparately coupled to bottom end cap 108 or another portion of lancingend 104 of device body 102. Lancing spring 130 can include a pluralityof springs, such as upper spring 130 a and lower spring 130 b(collectively referred to herein as lancing spring 130). Lancingmechanism 118 can include a stop 129, such as a tab or block, forsupporting lancing spring 130 or defining the stroke of lancing shaft122, in whole or in part. In at least one embodiment, such as theembodiment shown in FIG. 4, which is but one of many, stop 129 can bedisposed between lance coupling end 124 and actuating end 126 of lancingshaft 122. Upper spring 130 a can be coupled between stop 129 andactuating end 126, and lower spring 130 b can be coupled between stop129 and lance coupling end 124. Each lancing spring 130 a, 130 b can beloosely disposed about shaft 122 or can have one or more ends fixedlycoupled to shaft 122 or stop 129, separately or in combination. Eachlancing spring 130 a, 130 b can be any type of spring, or other biasingdevice, and can have any K value or length required by a particularapplication. Lancing shaft 122 can have a resting state, which can be atleast partially defined by communication between springs 130 a, 130 band stop 129, separately or in combination with one or more othercomponents of system 100. For example, when shaft 122 is at rest, one ormore of springs 130 a, 130 b can, but need not, be in their naturalstate (i.e., neither compressed nor extended). Alternatively, one ormore springs can be under tension or compression when lancing shaft 122is at rest or, as another example, while lancing shaft 122 is in motion,such as during lancing, as required by a particular application and aswill be understood by one of ordinary skill. When lancing shaft 122 isin a rest position, lance needle 120 b can, but need not, be distal froma surface 168 being lanced, such as skin (see, e.g., FIG. 5F). Lancingshaft 122 can be any length required by a particular application and canbe slideably coupled with stop 129 so that lancing spring 130 can biasshaft 122, such as in the upward or downward direction, as will befurther described below.

FIG. 5A is an illustration of one of many embodiments of a vacuum lancesystem 100 in a cocked position according to the disclosure. FIGS. 5B,5C and 5D are illustrations of the system 100 of FIG. 5A in threerespective positions during lancing. FIG. 5E is an illustration of thesystem 100 of FIG. 5A in an uncocked position. FIG. 5F is anillustration of the system 100 of FIG. 5A manipulating a surface duringlancing. FIG. 5G is an illustration of the system 100 of FIG. 5Avibrating a surface during lancing. At least one of many methods ofusing the embodiment of system 100 shown in FIGS. 5A-5G can bedescribed. FIG. 5H is a graph illustrating the vacuum magnitude versusthe time over which lancing can occur during a vacuum cycle. FIGS. 5A-5Hwill be described in conjunction with one another.

A lance 120 can be coupled to lancing mechanism 118, such as by usingone of the methods described herein, for example, before or after system100 is in a “cocked” position (see, e.g., FIG. 5A). System 100 can becocked, for example, by pressing knob 146 downward until at least aportion of main shaft 134, such as release coupler 140, couples withrelease mechanism 142, which can releasably hold main shaft 134 andpiston 148 downwardly toward lancing end 104, such as against the forceof vacuum spring 158. Shaft coupler second portion 160 b on mainactuating end 136 can couple to first portion 160 a of shaft coupler 160on actuating end 126 of lancing shaft 122. Actuating end 126 can, butneed not, move downwardly during cocking, temporarily or otherwise.Upper spring 130 a and lower spring 130 b can, but need not, be in theirnatural states. System 100 can engage a surface to be lanced (notshown), such as to an area of skin on a person's body, which can be anyarea. For example, seal 116 on lance guide 112 can engage the surface sothat at least a partially airtight seal is formed between seal 116 andthe surface.

System 100 can be activated, or fired, for example, by actuating release144, which can at least partially uncouple main shaft 134 and, forexample, release coupler 140, from release mechanism 142, which canallow main shaft 134 to slideably communicate with top end cap 110.Release 144 can be pressed directly, such as with a user's finger, orindirectly actuated, for example, using a magnet, electrical ormechanical actuator, or another method, as required by a particularapplication. Vacuum spring 158 can at least partially decompress (orlose tension if a tension spring, as mentioned above and furtherdescribed below) and piston 148, main shaft 134 and shaft coupler 160can move in the upward direction away from the surface being lanced.Piston 148, which can, but need not, include one or more seals, such asO-rings 150, can be in sliding sealing engagement with interior wall 152of device body 102, thereby at least partially forming a vacuum invacuum chamber 154 as piston 148 moves away from the surface beinglanced. One or more components of lancing mechanism 118, such asactuating end 126 and lancing shaft 122 can move upward with main shaft134, for example, due to the coupling force of shaft coupler 160 and theforce of expanding vacuum spring 158. Upper spring 130 a can expand andlower spring 130 b can contract, which can, for example, singularly orin combination, exert an increasing force on first portion 160 a ofshaft coupler 160 in the opposite direction (e.g., downward) of theforce exerted on second portion 160 b by vacuum spring 158 (e.g.,upward) as vacuum spring 158 expands (FIG. 5B). Lancing shaft 122 canhave a shorter stroke than main shaft 134. For example, stop 129 canlimit the stroke of lancing shaft 122, for example, by preventing atleast a portion of shaft 122 from traveling upward past the stop or, asanother example, lancing spring 130 (referring collectively to springs130 a and 130 b) can be arranged to limit the stroke of lancing shaft122, separately or in combination with stop 129. In at least oneembodiment, which is but one of many, lancing spring 130 can have, forexample, a length or K-value that can result in a lancing spring forcegreater than the coupler force of shaft coupler 160 when lancing shaft122 is in a particular position, which can be any position required by aparticular application.

Shaft coupler 160 can uncouple and second portion 160 b can continuemoving in the upward direction (FIG. 5C). Piston 148 can continue movingupward during and after penetration of the surface, continuously or insegments, such as by using two or more release couplers 140 thatsuccessively couple to release mechanism 142, which can increase thevacuum to which the surface can be exposed. Upper spring 130 a cancontract and lower spring 130 b can expand, singularly or incombination, which can, for example, cause first portion 160 a to movein the opposite (i.e., downward) direction from second portion 160 b ofshaft coupler 160. Lancing shaft 122 may be drawn back away from thesurface and the coupling force between portions 160 a and 160 b may beovercome. Lancing mechanism 118 can move toward a rest position, such asdue to the force of one or more springs 130. Lancing shaft 122 can movedownwardly, such as until at least a portion of lance 120 contacts thesurface (FIG. 5D). In at least one embodiment, which is but one of many,lancing shaft 122 can, but need not, move downwardly far enough thatupper spring 130 at least partially compresses and lower spring 130 b atleast partially expands as lance 120 lances the surface. As will beunderstood by one of ordinary skill, inertia may cause lancing shaft 122to move past its rest position (e.g., downward), for example, so thatlance needle 120 b may pierce the surface, before returning to its restposition. After at least partially penetrating the surface, each ofsprings 130 a, 130 b and lancing shaft 122 can return to a state of rest(FIG. 5E), and lance 120 can be disposed upwardly and distally from thesurface.

The surface can be subjected to a vacuum before, during, or afterlancing, separately or in combination. Air can enter vacuum chamber 154(selectively, automatically, or otherwise), such as through opening 156,which can dissipate the vacuum at any rate required by a particularapplication. Indicator 133, such as a tab, groove, or mark, can becomevisible, such as by passing outside of device body 102, which canindicate dissipation of the vacuum, in whole or in part. System 100 canbe disengaged from the surface, which can leave a quantity of blood onthe surface for collection.

A surface 168 being lanced can, but need not, be manipulated duringlancing, which can include twisting, pumping, pressing up and down, orany movement, separately or in combination (see, e.g., FIG. 5F). Forexample, where surface 168 is skin, one or more components on lancingend 104 of device body 102, such as lance guide 112 or seal 116, can beused to knead, massage or otherwise manipulate the skin at any timeduring the lancing process, for example, before, during or after theskin is lanced, which can result in a greater volume of blood 176 beingextracted and/or more rapid blood extraction. As an example of thismanipulation, seal 116 can be placed against the skin and twisted in oneor more directions, such as back and forth, clockwise, thencounterclockwise (or vice versa), for example, so that the skin twists,such as due to friction between the skin and seal 116, which canincrease blood flow to the area being lanced or out of an opening in theskin made by lance 120. The surface of seal 116 can be made of or coatedwith a gripping type substance, such as to aid in twisting the surfacewhen seal 116 is being twisted. Another example of this manipulation,which can speed up blood drawing, can include increasing and decreasinginward pressure of seal 116 on the surface in a pulse-like action. Eachof these classes of manipulation, just as with squeezing a finger if itis pricked, can speed up blood flowing through a lance-generated hole.This can be especially true in the presence of a vacuum on the surfaceas described in the present disclosure. The degree of manipulation, ifany, of the skin can vary from surface to surface on areas of the user,and from user to user, as will be understood by one of ordinary skillhaving the benefits of this disclosure.

With continuing reference to FIGS. 5A-5G, and further reference to FIG.5H, the timing and magnitude of vacuum creation and lancing can includeone or more variables, as will be understood by one of ordinary skill,each of which can have any value required by a particular application.The magnitude of the vacuum and the rate at which the vacuum can becreated, the timing of lancing, such as when shaft coupler 160uncouples, the rate at which lance 120 can travel, and the force withwhich lance 120 strikes a surface, or other factors can, but need not,be optimized for a particular application. Further, the vacuum creationcan occur in a single stage, or in multiple stages. For example, one ormore of these factors can be correlated with travel and timing of thepiston 148 along a length of device body 102. As will be understood byone of ordinary skill in the art, the further piston 148 travels withindevice body 102 (e.g., away from a surface being lanced), the higher avacuum in vacuum chamber 154 may be. Further, the force with which lance120 contacts a surface, such as skin, can be at least enough to punctureor penetrate the surface, and can advantageously drive at least aportion of needle 120 b through the surface and into subcutaneous tissuebeneath the surface from which blood may be taken. One or more variablescan be defined by the length and/or K value of a spring, such as oflancing spring 130 or vacuum spring 158, the volume of vacuum chamber154 or, as another example, by the weight, stroke or length of a shaft,such as lancing shaft 122 or main shaft 134.

In at least one embodiment, such as the embodiment shown in FIGS. 5A-5G,which is but one of many, the stroke of lancing shaft 122 can determinewhen shaft coupler 160 can uncouple during lancing and when lance 120can contact or penetrate the surface being lanced, such as during aperiod of time in which a vacuum can be applied to the surface. Forexample, upon release from a cocked position, piston 148 can travelupward from a lowermost position (see, e.g., FIG. 5A) where no vacuumexists within vacuum chamber 154 to an uppermost position (see, e.g.FIG. 5E), thereby creating a maximum vacuum within vacuum chamber 154,which can be any magnitude of vacuum, such as up to 30 inches ofmercury, required by a particular application.

As shown for illustrative purposes in FIG. 5H, lancing of a surface canoccur at any time before, during, or after a vacuum cycle, as may besuitable for a particular application. For example, the lancing of thesurface can occur before a vacuum is created, as indicated by referenceA. Alternatively, the lancing of the surface can occur while the vacuumis increasing in the device body, as indicated by reference B, such asat ½ of peak vacuum P. As will be understood by one of ordinary skillhaving the benefits of this disclosure, reference B illustrates one ofmany lancing times during vacuum creation, and lancing can alternativelyoccur at any point along a line between references A and C. The lancingcan also occur when the vacuum is at peak vacuum P, illustrated byreference C. In one or more other embodiments, lancing may occur afterpeak vacuum and before the vacuum has been entirely dissipated, such asat a point in time illustrated by reference D, which may be, forexample, ⅓P, or any point in time along a line between references C andE. As another example, lancing may occur after a vacuum has dissipated,such as at the point in time illustrated by reference E.

As described above, lancing can occur at any time during a vacuum cycle,including before, during, or after a vacuum is created, and canadvantageously occur when at least a partial vacuum is created, such asbetween 30% and 70%, or any increment there between, of the maximumvacuum for a particular application. In at least one embodiment, whichis but one of many, lancing can advantageously occur at between 40% and60% of vacuum creation, or any increment there between, such as at 50%vacuum creation. For example, the maximum vacuum can be −20 inHg, andthe surface can be lanced when the vacuum in vacuum chamber 154 is, forexample, −10 inHg. However, this need not be the case, and the examplesdescribed herein are for illustrative purposes. The timing of lancingcan, but need not, be adjustable. For example, in at least oneembodiment, such as a commercial embodiment, which is but one of many,system 100 can include a plurality of interchangeable lancing shafts,each of which can have a different length, which can determine whenlancing occurs during a vacuum cycle, as described above.

The rate at which the vacuum is created, which can be at least partiallydetermined by the rate at which piston 148 travels upward, can, but neednot, be adjustable. For example, in at least one embodiment, system 100can include a shock absorber, piston or other device (not shown), forcontrolling the rate at which piston 148 ascends during lancing. Thevacuum can be dissipated, or released, such as through opening 156, ormovement of piston 148, separately or in combination, at any rate and atany time required by a particular application. For example, where thesurface being lanced is skin, the vacuum can advantageously be releasedat a rate and time that may allow an adequate amount of blood forcollecting to be drawn from the surface or, as another example, at arate that can at least partially minimize blood splatter when the systemis removed from the skin.

With continuing reference to FIGS. 5A-5G, system 100 can, but need not,be adapted to vibrate during lancing. The term “vibrate” andconjugations thereof are used broadly herein and specifically include,without limitation, any shake, quiver, pulsation, or other movementapplied by lance system 100 to a surface being lanced. One or morevibrations can be timed to occur in proximity (e.g., in time and space)to lance penetration of a surface, which can mask the sensation ofpenetration from the user. Vibration in system 100 can at leastpartially mask pain associated with lancing, if any, such as where thesurface being lanced is skin. The vibration can be controlled byadjusting properties of one or more of the components, such as thedynamic components, of a particular embodiment of system 100, and canhave any magnitude or duration required by a particular application. Themagnitude of a vibration can depend on, or be predetermined by, forexample, the mass of one or more components in the system, the K valueof one or more springs, the stroke of one or more shafts, the momentumof one or more components, or other factors, as will be understood byone of ordinary skill having the benefits of this disclosure. One ormore vibrations can occur singularly, consecutively, concurrently,supplementary or otherwise, and can occur in, or transfer to, one ormore components of system 100. Advantageously, one or more vibrationsmay be present at lancing end 104, for example, so that the vibrationscan at least partially transfer to surface 168 during lancing (see, e.g.FIG. 5G), which can thereby aid in masking the pain of lancing. Thevibration can be caused by any of the components, such as the dynamiccomponents, of a particular embodiment of system 100, and can have anymagnitude or duration required by a particular application. Themagnitude of a vibration can depend on, or be predetermined by, forexample, the mass of one or more components in the system, the K valueof one or more springs, the stroke of one or more shafts, the momentumof one or more components, or other factors, as will be understood byone of ordinary skill having the benefits of this disclosure. In atleast one embodiment, which is but one of many, a vibration can beginbefore penetration of a surface, and can, at least partially, continueduring penetration of the surface. The vibration can advantageously, butneed not, continue after the surface has been lanced. As other examples,one or more components of lancing mechanism 118, such as lancing spring130 or lancing shaft 122, can cause vibration in system 100, separatelyor in combination with other components in the system.

In at least one embodiment, which is but one of many, one or moreportions of the lancing assembly, such as lancing shaft 122, lancecoupler 128, or main shaft 134, can move in a first direction, such astoward free end 106 of device body 102, for example, over a firstdistance. One or more of the portions, such as first portion 160 a ofshaft coupler 160, can be stopped from moving further in the firstdirection, such as further than the first distance, for example, by stop129, which can cause a vibration in one or more parts of system 100.Advantageously, the vibration continues to occur for an amount of timeat least long enough for the surface to be penetrated. One or morecomponents can move in a second direction, such as in a directionopposite the first direction, for example, toward the lancing end 104 ofdevice body 102. The one or more components, such as lancing shaft 122or first portion 160 a of shaft coupler 160, can be stopped from furthermoving in the second direction, for example, past a second distance,which can cause one or more vibrations in system 100.

FIG. 6 is a front isometric schematic view of one of many embodiments ofvacuum lance system 100 having a depth controller 162 according to thedisclosure. FIG. 7A is a cross-sectional schematic view of the system100 of FIG. 6. FIG. 7B is a cross-sectional schematic view of the system100 of FIG. 6 with a base contacting a spacer. FIG. 7C is across-sectional schematic view of the system 100 of FIG. 6 during bloodextraction. FIGS. 6-7C will be described in conjunction with oneanother. Vacuum lance system 100 can include a depth controller 162 forcontrolling the depth to which a surface is lanced during lancing. Depthcontroller 162 can include a calibrated spacer 164 and a spacer coupler166 for coupling spacer 164 to lancing end 104 of device body 102. Depthcontroller 162 can be formed from any material, such as plastic ormetal, and can be replaceably and interchangeably coupled to device body102 in any manner, such as being threaded thereon, forming aninterference or friction fit with one or more other components of system100, or fastened with fasteners, such as screws, brackets, adhesive, orother fasteners, removably, permanently or otherwise, and other methodof attachment. Alternatively, depth controller 162 can be fixedlycoupled to device body 102, integrally or otherwise, or any portionthereof. Depth controller 162 can, but need not, be transparent, inwhole or in part. Spacer coupler 166 can be tubular and can be coupled,for example, to lance guide 112 (see, e.g., FIG. 1) or, as anotherexample, in place of lance guide 112, as required by a particularapplication. Spacer 164 can be coupled to spacer coupler 166, includingbeing formed integrally therewith, between lance 120 and a surface 168being lanced. As another example, depth controller 162 can beadjustable, such as by way of one or more variable components, forexample, a spacer 164 of varying length or thickness, as will be furtherdescribed below (see, e.g., FIG. 18).

Spacer 164 can include a central opening, such as hole 170, for allowingat least a portion of lance 120 to pass there through, and can have acalibrated thickness “t”, which can be any thickness required by aparticular application, and which can be the same or different from thethickness of one or more portions of spacer coupler 166. Spacer 164 can,but need not, be adjustable, which can include being interchangeable,individually or simultaneously with spacer coupler 166, for example, toallow for spacers of different thicknesses. Hole 170 (having dimension“d” in FIG. 7A) can have any shape or cross-sectional area required by aparticular application, and can advantageously have a cross-sectionalarea larger than that of needle 120 b and smaller than that of base 120a (having dimension “D” in FIG. 7A) so that needle 120 b can passthrough hole 170 and base 120 a can not, i.e., D>d (see, e.g., FIG. 7B).Base 120 a can contact the upper surface 172 of spacer 164 duringlancing, which can limit the depth to which needle 120 b can penetratesurface 168, such as to the difference between length “l” of needle 120b and the thickness “t” of spacer 164. This can be advantageous, forexample, because the depth of penetration of needle 120 b into surface168 can be controlled regardless of the force with which lance 120travels in the downward direction during lancing, which can be anyforce. For example, where the surface 168 is skin, the force required tothrust lance 120 into the skin can vary from application to applicationand user to user, such as between relatively soft or thin skin andrelatively tough or thick skin, such as, for example, calloused skin.

Depth controller 162 can allow, for example, a relatively large force,such as a force large enough to lance calloused skin, to also be used onsofter areas of skin, for example, by stopping the travel distance ofneedle 120 b, so that regardless of its toughness, skin can be lanced toa depth of “l” minus “t” when the bottom surface 174 of the spacer 164is adjacent the skin, i.e., a depth equal to the difference between thelength “l” of lance needle 120 b and the thickness “t” of spacer 164. Asanother advantageous example, where the surface 168 being lanced isskin, a blunt force or vibration can result, such as from an impactbetween upper surface 172 and base 120 a, which can, but need not, maskpain that can result from lancing. In at least one embodiment, which isbut one of many, and is described herein only for illustrative purposes,lance 120, which can, but need not, be an off-the-shelf commerciallyavailable lance, can have a base 120 a having a dimension “D” (whichcan, but need not, be a diameter) of 0.250″ and a lance needle 120 bhaving a length “l” of 0.125″. Spacer 164 can have a thickness “t” of0.035″ and a hole 170 having a dimension “d” of 0.200″. As will beunderstood by one of ordinary skill having the benefits of thisdisclosure, this illustrative embodiment, for example, can penetrate thesurface 168 being lanced up to 0.090″ which is the difference betweenthe exemplary length “l” of needle 120 a and the exemplary thickness “t”of spacer 164. As another example, surface 168 can be penetrated up to0.065″ where spacer 164 has a thickness of 0.060″ and needle 120 b has alength of 0.125″.

The thickness “t” of spacer 164 can be any thickness required by aparticular application, wherein the greater the thickness “t”, thelesser the lance penetration depth, and vice versa, for a particularlength “l” of a needle 120 a required by a particular application. Thethickness “t” of a particular spacer 164 can advantageously allow atleast a portion of needle 120 b to penetrate surface 168, such as skinor another lancing surface, so that blood 176 may leave surface 168.Exemplary thicknesses of spacer 164 can include 0.100″, 0.080″, 0.060″,0.040″, and 0.020″, as well as thicknesses greater than, less than, orbetween such values. Spacer 164 can be calibrated for any surface, suchas for one or more areas of a user's skin. For example, spacer 164 canbe relatively thin for some surfaces, such as where blood vessels arescarce or more distant from the surface of the skin, or spacer 164 canbe relatively thick for other surfaces, for example, where blood may becloser to the skin, which can vary from application to application, orfrom user to user. Bottom surface 174 of spacer 164 can, but need not,be in direct contact with a lancing surface, for example, for allowinghole 170 to sealingly engage the surface. In at least one embodiment,for example, depth controller 162 can include an annular rim (notshown), which may comprise a seal, coupled to bottom surface 174 andextending downwardly to engage a lancing surface, singularly or incombination with bottom surface 174.

Depth controller 162 can include interchangeable or modular units, whichcan include interchangeable spacers 164 for a particular depthcontroller 162 or, as another example, interchangeable depth controllers162 for a particular system 100, wherein one or more depth controllers162 can, but need not, have spacers 164 of different calibratedthicknesses. Each interchangeable unit can be graduated and can, forexample, vary incrementally from unit to unit. In at least oneembodiment, which is but one of many, system 100 can include a pluralityof depth controllers 162, such as a set or kit, which can include aplurality of different depth controllers or spacers that can beselectively changed or switched by a user as required by a particularapplication. In at least one embodiment, which is but one of many, a setof depth controllers 162 may be stored, or storable, in a container,such as a bag or case, such as when not in use. A user can choose to useany of one or more depth controllers 162 required by a particularapplication, which can include choosing to use a depth controlleralready coupled to device body 102 or, as another example, can includechoosing a depth controller separate from device body 102 and couplingthe chosen depth controller to device body 102.

FIG. 8A is an illustration of one of many embodiments of a vacuum lancesystem having a lance tool 200 according to the disclosure. FIG. 8B isan illustration of a lance 120 being inserted into lance coupler 128with lance tool 200. FIG. 8C is an illustration of a lance 120 beingcoupled to lance coupler 128 with lance tool 200. FIG. 8D is anillustration of a lance 120 being removed from lance coupler 128 withlance tool 200. FIGS. 8A-8D will be described in conjunction with oneanother. Vacuum lance system 100 can include a lance tool 200 forcoupling and uncoupling a lance 120 with lance coupling end 124 oflancing shaft 122, such as to lance coupler 128, safely andconveniently. Lance tool 200 can include a lance tool body 202 and oneor more couplers, such as, for example, lance insertion coupler 204 andlance removal coupler 206, which can, but need not, be tubular. Forexample, insertion coupler 204 and removal coupler 206 can, but neednot, have annular cross-sections and/or one or more longitudinal slotsto allow lance 120 to be inserted therein, as will be understood by oneof ordinary skill.

To install lance 120 into system 100, for example, lance 120 can beinserted into insertion coupler 204 “needle end first” so that theneedle 120 b of lance 120 is inside insertion coupler 204 and so thatbase 120 a of lance 120 couples with insertion coupler 204 and at leasta portion of base 120 a protrudes from insertion coupler 204 (see, e.g.,FIG. 8B). In at least one embodiment, which is but one of many, base 120a and insertion coupler 204 can form a clearance fit or, as anotherexample, an interference fit less than an interference fit between lancecoupler 128 and base 120 a. Insertion coupler 204 and lance 120 can bemoved toward lancing end 104, as indicated by the arrows in FIG. 8B, anddisposed so that the portion of base 120 a protruding from insertioncoupler 204 couples with lance coupling end 124 of lancing shaft 122,such as to lance coupler 128 (see, e.g., FIG. 8C). For example, asmentioned above, lance base 120 a can form an interference fit withlance coupler 128 so that lance 120 uncouples from insertion coupler 204and remains seated in lance coupler 128 for lancing when lance tool 200is removed from lance guide 112, as indicated by the arrow in FIG. 8C.

To remove lance 120 from lance coupler 128, for example, lance removalcoupler 206 can be inserted into lance guide 112 until removal coupler206 passes over needle 120 b and couples to base 120 a of lance 120. Forexample, removal coupler 206 and base 120 a can form an interferencefit, such as an interference fit having a greater interference (i.e., atighter fit) than the interference fit formed between base 120 a andlance coupler 128. Lance tool 200 and lance 120 can be moved away fromlance coupler 128, as indicated by the arrows in FIG. 8D, and lance 120can uncouple from lance coupler 128 and remain coupled to removalcoupler 206, which can remove lance 120 from lance coupling end 124.Although lance insertion coupler 204 and lance removal coupler 206 ofthe lance tool 200 have been described herein to communicate with lance120 using one or more “fits,” such as an interference or clearance fit,this need not be the case, and, alternatively, each coupler 204, 206 cancouple with lance 120 in any manner required by a particularapplication, as will be understood by one of ordinary skill in the art.As one example, which is but one of many, lance 120 can threadablycouple to lance coupler 128, and one or more of couplers 204, 206 of thelance tool 200 can include a notch, groove, or other structure forcommunicating with lance 120, such as in a complementary fashion,separately or in combination with a particular fit, for example, forscrewing lance 120 into or unscrewing lance 120 from lance coupler 128.

In at least one embodiment of lance system 100, which is but one ofmany, lance tool 200 can be coupled to lance device body 102, such as tothe exterior along its length, when not in use. For example, lancedevice body 102 or lance tool 200 can, but need not, have at least oneholder 208, such as complementary couplers, mounted thereon, such as,for example, magnets, hook and loop material, snaps or other fasteners.As other examples, device body 102 can have a hook, brace, grip or otherholder coupled thereto and adapted to hold lance tool 200, such as bytool body 202, or device body 102 can have a stud or bracket adapted tocouple to insertion coupler 204 or removal coupler 206. Lance tool 200can be formed from any material required by a particular application,such as plastic, metal or another material, and can be any shape orsize, as will be understood by one of ordinary skill in the art havingthe benefits of this disclosure.

FIG. 9 is a cross-sectional schematic view of one of many embodiments ofa vacuum lance system 300 having an external vacuum indicator 302according to the disclosure. For purposes of clarity, the same referencenumerals as those used previously herein will be used in some instances,while new reference numerals will be used to reference components thatmay not have been described above. It should be understood that althoughthe same reference numeral may be used to reference a component in twoor more Figures, the component can, but need not, be exactly the same inpractice, as required by a particular embodiment or application.

Lance system 300 can generally function similarly to one or more of theother embodiments described herein, and can include an external vacuumindicator 302 coupled to device body 102 for indicating whether a vacuumis present in the system. Indicator 302 can include an indicator body304 coupled in fluid communication with vacuum chamber 154, such as withindicator air tube 306, which may be any type of conduit. Indicator 302can include a marker 310 sealingly coupled inside indicator body 304 andan indicator spring 308 coupled between marker 310 and vacuum chamber154. Indicator 302 can include a viewing window 312 for viewing marker310, such as, for example, when no vacuum exists in the system. Window312 can be coupled anywhere to indicator body 304, for example, to thetop or side, and can be any size. For example, window 312 can, but neednot, be at least a portion of indicator body 304 and can be at leastpartially transparent, such as a thin transparent strip along the lengthof indicator body 304. Alternatively, for example, indicator body 304can be wholly transparent.

Indicator 302 can be coupled to device body 102 in any location betweena surface being lanced and piston 148. Indicator 302 can be an “L-type”indicator (as shown in FIG. 9), for example, so that indicator body 304is parallel to device body 102, a “T-type” indicator, for example, sothat indicator body 304 is perpendicular to device body 102 or, asanother example, indicator 302 can be disposed at another angle, whichcan be any angle, relative to central longitudinal axis X of the system.

As a vacuum is created in system 300 during lancing, marker 310, such asa disk or other indicator, can travel toward tube 306, and, for example,spring 308 can be compressed. Marker 310 can, but need not, becomeinvisible. As the vacuum is released during lancing, marker 310 can movealong tube 306 and spring 308 can expand, which can move at least aportion of marker 310 into view, such as being visible through window312. While indicator spring 308 can be shown to be a compression springin FIG. 9 for illustrative purposes, it need not be, and canalternatively be a tension spring, or both, separately or incombination, as will be understood by one of ordinary skill.

With further reference to FIG. 9, system 300 can include at least oneopening between vacuum chamber 154 and an atmosphere surrounding thevacuum chamber, as described above (see, e.g., FIG. 5A). For example,and without limitation, the embodiment of FIG. 9, which is but one ofmany, can include three openings 156A, 156B and 156C (collectively“opening 156”), but this need not be the case and, alternatively, system300 may include any number of openings 156, such as one, two, or more,or none, as required by a particular application. Each opening 156, suchas one or more of openings 156A-C, can be in piston 148, device body102, or another portion of system 300, separately or in combination.Like the embodiment of FIG. 9, any embodiment of the present invention,such as one or more of the other embodiments shown or described herein,may include any number of openings 156 disposed in any location requiredby a particular application, separately or in combination, as will beunderstood by one of ordinary skill having the benefits of the presentdisclosure. While one or more openings 156 in a particular embodimentcan afford a linear vacuum dissipation rate (see, e.g., FIG. 5H), thisneed not be the case and, alternatively, a rate of vacuum dissipationcan be non-linear, as required by a particular application.

FIG. 10 is a cross-sectional schematic view of one of many embodimentsof a vacuum lance system 400 having an external vacuum assembly 402according to the disclosure. System 400 can include a lancing assembly404 for lancing a surface, which can be any lancing assembly required bya particular application. Lancing assembly 404 can, but need not,include a vacuum mechanism coupled with main device body 408, such as,for example, one or more of the embodiments described herein, partially,separately or in combination. System 400 can include a lance 120, suchas a commercially available lance, and a vacuum chamber 406, which can,but need not, extend at least partially inside main device body 408.System 400 can include an external vacuum assembly 402 for at leastpartially creating a vacuum in vacuum chamber 406. Vacuum assembly 402can, but need not, be a second, additional or supplementary source ofvacuum in system 400, and can operate separately or in combination withone or more other components, such as vacuum components, lancingcomponents, or other components of system 400.

Vacuum assembly 402 can include a vacuum body 410 for supporting one ormore components of the system. Vacuum body 410 can be tubular and canhave a vacuum end 412 and a longitudinally opposite end 414. Vacuum body410 can, but need not, be coupled to main device body 408, rigidly,removably, or otherwise. Vacuum assembly 402 can include a shaft 416,which can be slideably coupled to end 414. Vacuum assembly 402 caninclude a release mechanism 418 coupled, for example, to end 414 ofvacuum body 410, which can cooperate with shaft 416 to removably holdshaft 416 or one or more other components in one or more positions.Vacuum assembly 402 can include a piston 420, which can be in sealingengagement with vacuum body 410, such as with an inner surface 422, forexample, for creating, increasing the level of, or dissipating a vacuumwithin vacuum chamber 406. Piston 420 can, but need not, include anopening (see, e.g., FIG. 5E) therein for allowing fluid communicationbetween vacuum chamber 406 and an atmosphere surrounding vacuum chamber406. Vacuum assembly 402 can include one or more springs, such as spring424, for biasing piston 420 in one or more directions, for example,toward end 414 of vacuum body 410. Vacuum assembly 402 can be fluidiclycoupled to vacuum chamber 406, for example, by conduit 426, which can beany conduit, such as a pipe, tube or other conduit, for routing fluid.Therefore, vacuum chamber 406 can include conduit 426 and at least aportion of vacuum body 410.

The embodiment shown in FIG. 10, which is but one of many, can generallyoperate or function similarly to one or more other embodiments describedherein, such as to create or release a vacuum, in whole or in part, invacuum chamber 406. For example, vacuum assembly 402 can create at leasta portion of a vacuum in vacuum chamber 406 and lancing assembly 404 canlance a surface before, during, or after the vacuum exists. Vacuumassembly 402 can, but need not, create or dissipate a vacuum inportions, such as segments or stages, for example, by movement of piston420 in one or more directions. Vacuum assembly 402 can cooperate withlancing assembly 404 to form a vacuum, in whole or in part, for example,in an embodiment, which is but one of many, wherein lancing assembly 404includes a vacuum mechanism or can otherwise be able to create at leasta portion of a vacuum independent of vacuum assembly 402. Penetration ofa surface can occur at any time during lancing, such as at apredetermined time during vacuum creation, as required by a particularapplication.

Having described above one or more exemplary embodiments of the presentinvention, another one of many embodiments will now be described. Forpurposes of clarity, the same reference numerals as those usedpreviously herein will be used in some instances, while new referencenumerals will be used to reference components that may, but need not,differ from those described above, in whole or in part. It should beunderstood that although the same reference numeral may be used toreference a component in two or more of the Figures, the component can,but need not, be exactly the same in practice, as required by aparticular embodiment or application, and reference numerals used hereinare arbitrarily chosen for ease of explanation. One or more of thecomponents and principles described above are also applicable to thefollowing embodiments, and vice versa, regardless of whether likereference numerals are used, as will be readily understood by one ofordinary skill in the art. Certain details may not be repeated forpurposes of brevity and the avoidance of unnecessary repetition,although such details can apply uniformly to all embodiments of thepresent invention.

FIG. 11 is an isometric schematic view of another of many embodiments ofa vacuum lance system according to the disclosure. FIG. 12 is anisometric assembly schematic view of the vacuum lance system of FIG. 11.FIG. 13A is a cross-sectional schematic view of the vacuum lance systemof FIG. 11 in a cocked position. FIG. 13B is a cross-sectional schematicview of the vacuum lance system of FIG. 11 in an uncocked position. FIG.14 is a cross-sectional schematic view of one of many embodiments of alancing mechanism according to the disclosure. FIG. 14A is across-sectional schematic view of the release mechanism of FIG. 14coupled to the main shaft before activation. FIG. 14B is across-sectional schematic view of the release mechanism of FIG. 14Auncoupled from the main shaft after activation. FIG. 14C is a schematicview of yet another of many embodiments of a release mechanism in adeactivated position according to the disclosure. FIG. 14D is aschematic view of the release mechanism of FIG. 14C in an activatedposition according to the disclosure. FIG. 14E is a schematic view ofyet another of many embodiments of a release mechanism in a deactivatedposition according to the disclosure. FIG. 14F is a schematic view ofthe release mechanism of FIG. 14E in an activated position according tothe disclosure. FIGS. 11-14F will be described in conjunction with oneanother.

Vacuum lance system 500 can include a device body 102, which can includeone or more end caps 108, 110, coupled thereto or formed integrallytherewith, in whole or in part. A lancing mechanism 518 can be coupledto body 102, such as to lancing end 104, for supporting a lance 120(also known as a “lancet”). Lancing mechanism 518 can include a lancingshaft 122 slideably coupled with end cap 108, such as along centrallongitudinal axis X, for communicating lance 120 with a surface duringlancing. Lancing shaft 122 can include a bottom lance coupling end 124and a top actuating end 126. Lancing mechanism 518 can include a lancecoupler 128 coupled to lance coupling end 124 for coupling lance 120 toshaft 122, removably or otherwise. Lancing mechanism 518 can include oneor more biasing devices, such as a lancing spring 130. Lancing spring130 can be coupled to lancing shaft 122 for biasing shaft 122 in one ormore directions, temporarily, momentarily or otherwise, as will befurther described below. Lancing spring 130 can, but need not, comprisea plurality of springs, and can advantageously include two springs.

System 500 can include a release mechanism 542, such as a firingassembly, which can include a release 144, one or more release couplers,and one or more components coupled there between, as further describedbelow. Release mechanism 542 can include structure for cooperating withother components of system 500, such as lancing mechanism 518, vacuummechanism 532, or other elements of the system, separately or incombination. Release mechanism 542 can be any type of releasablecoupling system for lancing, and can be adapted to cooperate with mainshaft 134, such as by optionally coupling with release coupler 140,piston 148, and/or other system components coupled to shaft 134, toreleasably hold main shaft 134 in one or more positions. In at least oneembodiment, release 144 can sealingly engage one or more portions of thesystem, such as body 102 or end cap 108, which can, but need not includeone or more seals 153, such as an 0-ring, gasket, or other device for atleast partially limiting the entrance or escape of fluid, such as intoor out of body 102 or vacuum chamber 154. At least three possibleembodiments of release mechanism 542, which are but three of many, willnow be described with reference to FIGS. 14-14F for illustrativepurposes.

As one example, in the embodiment of FIGS. 14-14B, which is but one ofmany, release mechanism 542 can include a second release coupler 141,such as a catch or hook, for releasably coupling with coupler 140, suchas a notch or groove (or vice versa) in any manner required by aparticular application. The system can, but need not, include one ormore retainers 143, such as a ring, washer, gasket, disk or otherstructure or fastener, for at least partially holding coupler 141 inplace. Release mechanism 542 can include one or more biasing devices,such as spring 147, for biasing at least a portion of the mechanism,such as release 144 or coupler 141, in one or more directions, and caninclude one or more couplers or fasteners, such as pin 149, for couplingone or more mechanism components together. For example, pin 149 cancouple release 144 and coupler 141 for translating motion therebetween.Pin 149 can pass through an opening 151 in stop 129, such as a slot,hole, or other opening. Spring 147 can bias release 144 toward adeactivated position, for example, radially outwardly, and can biascoupler 141, such as by biasing pin 149, toward a position for couplingwith main shaft 134, such as with coupler 140. In a cocked position(e.g., FIG. 14A), couplers 140, 141 can be coupled and can hold piston148 and main shaft 134 in a downward or other energized position. Forexample, catch 141 a can be disposed adjacent to wall 140 a forretaining piston 148 and main shaft 134, such as in a pre-firingposition against the force 158 a of vacuum spring 158.

With reference to FIG. 14B, release mechanism 542 can be activated bymoving release 144 toward an activated position for allowing couplers140, 141 to uncouple from one another. For example, by pressing release144 radially inwardly (as illustrated by the vertical arrow in FIG.14B), such as by sliding with a user's finger, or by another manner,including electronically, catch 141 a can move from a cocked positionadjacent to wall 140 a to an activated position out of the way ofcoupler 140, which can allow couplers 140, 141 to uncouple. For example,catch 141 a can be moved from a pre-firing position so that piston 148and main shaft 134 are no longer retained against the force of vacuumspring 158, which can allow piston 148 and main shaft 134 to move towardan uncocked or deenergized position (e.g., to the right as illustratedby the horizontal arrow in FIG. 14B) as vacuum spring 158 compresses ordeenergizes.

Turning to FIGS. 14C, 14D, as a second example, release 144 and coupler141 alternatively can be formed integrally as a single component and pin149 (FIG. 14A) can, but need not, be absent. In such an embodiment,which is but one of many, release 144 and coupler 141 can be made atleast partially from elastic material, such as one or more elastomers(e.g., rubber) or shape-memory metals, separately or in combination, andspring 147 (FIG. 14A) can, but need not, be absent, as will beunderstood by one of ordinary skill in the art. For example, release 144can be mushroom-shaped with its hat 144 a adjacent the exterior of endcap 108, body 102, or a coupler 702 coupled thereto, such as a washer,grommet or seal, and its stem 144 b extending radially inwardly towardrelease coupler 141. The elasticity of the material from which release144, or one or more other system components, can be at least partiallyformed can allow a user to at least temporarily push or otherwise deformrelease 144 to activate system 500 (e.g., FIG. 14D), and can return theone or more pressed components, such as release 144 or other components,to a default position and can return the coupler 141 to a rest position(e.g., FIG. 14C) in a spring-like fashion. For example, as shown forexemplary purposes in FIG. 14C, release 144 can bias release coupler 141in the upward direction (as illustrated) so that at least a portion ofthe coupler 141, such as catch 141 a, interferes or otherwise coupleswith coupler 140, such as with wall 140 a, for cocking the system. Auser can apply a deforming or activating force or pressure (such as byapplying a finger) to release 144, and the elastic resistance of release144, which can be of any magnitude required by a particular application,can be at least partially overcome. Release 144 can force or push catch141 a some distance Ad, which can be any distance required by aparticular application. Catch 141 a can move out of a position ofinterference with wall 140 a, which can allow piston 148 to move to theright (as illustrated) during firing of the system (FIG. 14D). Thus, aswill be readily understood by one of ordinary skill in the art havingthe benefits of the present disclosure, the embodiment of FIGS. 14C, 14Doperates similarly to that of FIGS. 14A, 14B, although the mechanics ofone or more elastic components in the former can be substituted forthose of one or more springs 147 in the latter, in whole or in part,separately or in combination.

A third example of a release mechanism, which is but one of many inaccordance with the present disclosure, is shown in FIGS. 14E-14F. In atleast one embodiment, release mechanism 542 can include a wishbone- orwedge-type mechanism for selectively holding piston 148 and main shaft134 in a cocked position. For example, release mechanism 542 can includea U- or C-shaped coupler 601, such as a C-ring, circlip, snap ring orother coupler, and at least one wedge 602 for defining a path ofmovement of at least a portion of coupler 601, such as ends 601 a, 601b. Wedge 602 can include any structure (or structures) that cancooperate with coupler 601 as described herein, such as one or moreblocks or tapers. Coupler 601 can include one or more tabs 603, such asprojections or other retainers, for coupling with one or more othercomponents of the system, such as main shaft 134, piston 148 or releasecoupler 140. Coupler 601 can expand and contract against wedge 602,which can respectively increase and decrease a distance between tabs 603for allowing tabs 603 to releasably couple and uncouple with shaft 134,such as by selectively retaining release coupler 140. In a cockedposition (e.g., FIG. 14E), tabs 603 can be coupled with coupler 140,such as by being disposed adjacent thereto, and can hold piston 148 andmain shaft 134 in a downward or other energized position, such asagainst the force 158 a of vacuum spring 158. Release mechanism 542 canbe activated by disposing coupler 601 in an activated position (e.g.,FIG. 14F), for example, by pressing release 144 radially inwardly (asshown by the arrow in FIG. 14F for illustrative purposes), which canallow ends 601 a, 601 b to slide and spread against wedge 602, therebyat least partially separating tabs 603. Tabs 603 can uncouple fromcoupler 140, such as by moving radially outwardly from piston 148 orcoupler 140, which can allow piston 148 and main shaft 134 to movetoward an uncocked or deenergized position. Other types of releasemechanisms can be coupled with system 500, separately or in combinationwith one or more of those specifically described herein, in whole or inpart, as will be readily understood by one of ordinary skill having thebenefits of the present disclosure. For example, although coupler 601 isshown in FIGS. 14E-14F for illustrative purposes to expand and contractagainst a wedge 602, coupler 601 could alternatively expand and contractbetween two or more opposing wedges or surfaces (not shown) to couple oruncouple with a corresponding release coupler 140, as will be readilyunderstood by one of ordinary skill having the benefits of thisdisclosure.

System 500 can include a vacuum mechanism 532 for creating a vacuum andcooperating with lancing mechanism 518 or other components of the systemduring lancing. Vacuum mechanism 532 can include a main shaft 134 with abottom main actuating end 136 and a top main free end 138, and at leastone release coupler 140, which can, but need not, be coupled to piston148. System 500 can, but need not, include a knob 146, such as a buttonor cap coupled to main free end 138. Vacuum mechanism 532 can includeone or more pistons, such as piston 148, coupled to main shaft 134 forcooperating with one or more other components of system 500 to create avacuum. Piston 148 can be coupled, adjustably, fixedly or otherwise,anywhere on main shaft 134 inside of device body 102, such as, forexample, to main actuating end 136, and can at least partially form avacuum chamber 154 inside device body 102. System 500 can include one ormore openings 556, such as an air passage or orifice, for fluidcommunication between vacuum chamber 154 and an atmosphere surroundingthe vacuum chamber. System 500 can include one or more openings betweenother portions of the interior of body 102 and the atmosphere, such asopening 557, for example, for allowing fluid (e.g., air) to flow in orout of body 102 as piston 148 moves along the body's length. Opening 557can be disposed anywhere in the system, such as in free end 106 of thebody, cap 110, or another location. Opening 556 can be calibrated toallow air to flow into vacuum chamber 154 at a predetermined vacuumdissipation rate, which can be any rate required by a particularapplication. Opening 556 can be any suitable place for fluidiclycommunicating with a vacuum in system 500, such as in device body 102,and can advantageously be, but need not be, in release 144. One or moreopenings 556 can afford any rate of vacuum dissipation required by aparticular application, such as a linear rate, non-linear rate, oranother rate, in whole or in part, separately or in combination.

Vacuum mechanism 532 can include a biasing device, such as vacuum spring158, coupled to piston 148 for biasing piston 148 in one or moredirections, such as in the upward direction toward free end 106. Forexample, vacuum spring 158 can include a tension spring, as shown in theembodiment of FIG. 12, which is but one of many, so that a rest positionfor release coupler 140 can be toward top end cap 110. System 500 can,but need not, include a vacuum indicator (such as one or more of thevacuum indicators described above; see, e.g., FIG. 2) for indicatingwhether or to what extent a vacuum exists within vacuum chamber 154. Forexample, in an application where skin is being lanced for purposes ofdrawing blood, it could at times be detrimental for the user to pullsystem 500 off the skin when there is still vacuum in chamber 154because inrushing air could disperse or otherwise disrupt withdrawnblood pooled on the surface. For this reason, it can be advantageous forthe user to know the vacuum level in chamber 154. A vacuum indicator canbe calibrated to indicate when system 500 can be removed from the skinfor at least minimizing any potential that drawn blood could splatter.

With further reference to FIGS. 12-14, system 500 can include a shaftcoupler 160 for releasably coupling one or more components of thesystem, such as lancing shaft 122 and main shaft 134. For example, shaftcoupler 160 can include a first portion 160 a coupled to lancing shaft122, such as to actuating end 126, and a second portion 160 b coupledwith main shaft 134, whether directly or indirectly, such as with piston148. Lancing mechanism 518 can include a stop 129, such as a tab, block,disk or other structure, for supporting lancing spring 130 and defininga stroke of lancing shaft 122, in whole or in part. For example, upperspring 130 a can be coupled between stop 129 and actuating end 126, andlower spring 130 b can be coupled between stop 129 and lance couplingend 124. Stop 129 can be coupled with body 102, such as to end cap 108,in any manner required by a particular application, which may, but neednot, include the use of one or more fasteners 145, such as screws, pins,adhesives, or other holding devices, separately or in combination.Alternatively, no fasteners 145 need be used, and stop 129 can becoupled with body 102 in another manner, such as by force or frictionfit, or can be formed integrally with cap 108, in whole or in part.

FIG. 15A is an illustration of the vacuum lance system of FIG. 11 in acocked position according to the disclosure. FIG. 15B is an illustrationof the vacuum lance system of FIG. 15A in one of many activatedpositions wherein the first and second portions of the shaft coupler arecoupled according to the disclosure. FIG. 15C is an illustration of thevacuum lance system of FIG. 15A in another of many activated positionswherein the first and second portions of the shaft coupler are uncoupledaccording to the disclosure. FIG. 15D is an illustration of the vacuumlance system of FIG. 15A in another of many activated positions whereinthe opening in the release is sealed according to the disclosure. FIG.15E is an illustration of the vacuum lance system of FIG. 15A in anotherof many activated positions wherein the opening in the release is notsealed according to the disclosure. FIG. 15F is an illustration of thesystem of FIG. 15A in an uncocked position. At least one of many methodsof using the embodiment of system 500 shown in FIGS. 15A-15F can bedescribed. FIG. 15G is a graph illustrating another example of vacuummagnitude versus a time over which lancing can occur during a vacuumcycle according to the disclosure. FIGS. 15A-15G will be described inconjunction with one another.

A lance 120 can be coupled to lancing mechanism 518, such as by usingone of the methods described herein, for example, before or after system500 is in a “cocked” position (see, e.g., FIG. 15A). A lance guide, suchas depth controller 162, can be coupled to lancing end 104, such as withend cap 108. System 500 can be cocked, for example, by pressing knob 146downward until release coupler 140 couples with release mechanism 142,such as by releasably engaging coupler 141. First and second portions160 a, 160 b of shaft coupler 160 can couple together to releasablycouple the actuating ends of shafts 122, 134. Actuating end 126 can, butneed not, move downwardly during cocking, temporarily or otherwise.Upper spring 130 a and lower spring 130 b can, but need not, be in theirnatural states. System 500 can contact a surface to be lanced (notshown), such as an area of skin on a person's body, which can be anyarea, and can advantageously form an at least partially airtight sealbetween depth controller 162, or a portion thereof, such as seal 116,and the surface. Seal 116 can be formed integrally with depth controller162 (as shown for illustrative purposes) or can be a separate structurecoupled to depth controller 162, separately or in combination.

A user can place his or her finger on release 144 in preparation forfiring the system and opening 556 can advantageously be at leasttemporarily closed, for example, to at least substantially seal vacuumchamber 154 among body 102, piston 148 and the surface to be lanced. Asshown in the embodiment of FIGS. 15A-15F, which is but one of many,opening 556 can advantageously be disposed through release 144, forexample, so that a user can simultaneously block, plug or otherwiseobstruct opening 556 upon engaging release 144 with a finger or otheractuator (such as a glove or other object). However, this need not bethe case, and, alternatively or collectively, opening 556 can be locatedelsewhere, such as through body 102 or cap 108, and a user may close theopening(s) in another manner, such as by using another finger. Asanother example, system 500 can include a valve (not shown), such as aball valve, needle valve, or other device for regulating or directingfluid flow, for electively starting, stopping or otherwise controllingflow through one or more openings, such as opening 556.

As indicated by the arrows in FIGS. 15B-15C, system 500 can be activatedby actuating (e.g., pressing inwardly) release 144, which can coupler140 and coupler 141 to disengage or otherwise uncouple. Vacuum spring158 can at least partially contract and piston 148, main shaft 134 andshaft coupler 160 can move in the upward direction away from the surfacebeing lanced. Piston 148 can at least partially form a vacuum in vacuumchamber 154 as piston 148 moves away from the surface being lanced, andopening 556 can remain closed, for example, to sustain the sealedchamber. One or more components of lancing mechanism 118, such asactuating end 126 and lancing shaft 122 can move upward with main shaft134, for example, due to the coupling force of shaft coupler 160 and theforce of contracting vacuum spring 158. Upper spring 130 a can expandand lower spring 130 b can contract, which can, for example, singularlyor in combination, exert an increasing force on first portion 160 a ofshaft coupler 160 in an opposite direction (e.g., downward) from a forceexerted on second portion 160 b by vacuum spring 158 (e.g., upward) asvacuum spring 158 contracts (FIG. 15B). Lancing shaft 122 can contactstop 129, which can limit a stroke of lancing shaft 122.

Shaft coupler 160 can uncouple and second portion 160 b can continuemoving in an upward direction (as illustrated in the FIGS. forillustrative purposes) while first portion 160 a and lancing shaft 122reverse and move in an opposite (e.g., downward) direction toward thesurface to be lanced (FIG. 15C). Lance 120 can penetrate the surface andlancing mechanism 518 can return to a state of rest. Piston 148 cancontinue moving upwardly at least partially toward free end 106. Aspiston 148 moves toward free end 106, such as under the force of spring158, a magnitude of vacuum formed in vacuum chamber 154 can graduallyincrease and opening 556 can remain closed (FIG. 15D). The vacuum cangenerate a force acting on piston 148 in a direction opposite a force ofspring 158 (e.g., downwardly), and the magnitude of the vacuum force caneventually become greater than or equal to that of the spring force, forexample, so that piston 148 can at least partially come to rest betweenits cocked and uncocked positions (FIG. 15E) along the length of body102, which may occur anywhere along the length of the body or stoke ofshaft 134 as required by a particular application.

At this point in the exemplary vacuum assisted lancing process, themagnitude of the vacuum can, but need not, be at least substantiallyconstant, and the vacuum can act on the lanced surface, which canadvantageously result in suction that at least partially draws, or helpsdraw, blood from the surface. The user can maintain the state of vacuumin vacuum chamber 154 by keeping opening 556 closed, for example, bykeeping his or her finger sealingly disposed there against, which can,but need not, include holding release 144 at least partially in anactuated position (e.g., inwardly, as indicated by the arrow in FIG.15E). The user can view the area in which the surface has been pierced,such as through viewing area 114, which can, but need not, be at least aportion of a lance guide (see, e.g., FIG. 1) or a depth controller 162,and can advantageously verify whether or when a desired amount of blood,such as enough blood for testing, has exited from the surface. Althoughthe Applicant expects that a requisite or desired amount of blood willoften be recognized by a user through experience in lancing and bloodextraction, this need not be the case, and a volume of extracted bloodcan be quantified by other measures. For example, in at least oneembodiment of the system, hole 170 can be sized or calibrated, such asthrough one or more dimensions, to contain a minimum volume of extractedblood required by a particular application.

In these manners, it will be apparent that a user can advantageouslymaintain the vacuum on the surface until a desired amount of blood isextracted, and, for example, can thereafter electively commencedissipation of the vacuum by opening or unblocking one or more openings556, such as by removing his or her finger from release 144 and opening556 (e.g., as indicated by the vertical arrow in FIG. 15F). Unblockingopening 556 can allow air to flow into vacuum chamber 154, and piston148 can resume travel (e.g., as indicated by the horizontal arrow inFIG. 15F) toward free end 106 until, for example, vacuum mechanism 532comes to rest in an uncocked position (FIG. 15F). The vacuum can bedissipated at any rate required by a particular application, and canadvantageously be dissipated at a relatively rapid rate by unblockingthe opening as soon as the user observes or verifies that a sufficientamount of blood, such as an amount adequate for testing, has beenextracted. Such an advantage can at least partially minimize the amountof time over which the system contacts the skin while at the same timeproviding the user with a readily attainable indication that the elapsedtime and vacuum magnitude have been sufficient for drawing a requiredamount of blood for the purpose of a particular application. At theuser's option, such as can be determined from the user's visualfeedback, system 500 can be disengaged from the surface, which can leavea quantity of blood in a pool on the surface for collection.

As explained above with reference to one or more other embodiments ofthe present invention, the surface can be subjected to a vacuum before,during, or after lancing, separately or in combination. Air can enter orleave vacuum chamber 154 and body 102 at any rate required by aparticular application. A surface being lanced can, but need not, bemanipulated during lancing, which can include twisting, pumping,pressing up and down, or any movement, separately or in combination(see, e.g., FIG. 5F). With continuing reference to FIGS. 15A-15F, andfurther reference to FIG. 15G, the timing and magnitude of vacuumcreation and lancing can include one or more variables, as will beunderstood by one of ordinary skill, each of which can have any valuerequired by a particular application. For example, the magnitude of thevacuum, the rate at which the vacuum can be created, the timing oflancing, such as when shaft coupler 160 uncouples, the rate at whichlance 120 can travel, and the force with which lance 120 strikes asurface, or other factors, can be optimized for a particularapplication. Vacuum creation can occur in a single stage, or in multiplestages.

As shown for illustrative purposes in FIG. 15G, lancing of a surface canoccur at any time before, during, or after a vacuum cycle, as may besuitable for a particular application. For example, lancing of thesurface can occur before a vacuum is created, as indicated by referenceA. Alternatively, lancing can occur while the vacuum is increasing inthe device body, as indicated by reference B. As will be understood byone of ordinary skill having the benefits of this disclosure, referenceB illustrates one of many lancing times during vacuum creation, andlancing can alternatively occur at any point along a line betweenreferences A and C. As another example, lancing can occur when thevacuum is at peak vacuum P, illustrated by reference C. In at least oneembodiment of the present invention, such as, for example, theembodiment shown and described in FIGS. 15A-15F, the magnitude ofvacuum, such as peak vacuum P, can be maintained for a period of vacuumholding time after lancing has occurred, as indicated by line CD. Aholding time can be any period of time required by a particularapplication or otherwise chosen by a user, such as an amount of timesufficient to allow a desired amount of blood to exit the surface. Auser can allow the vacuum to dissipate, in whole or in part, or cancommence dissipation of the vacuum, at a timing of their choosing, forexample, through manipulation of opening 556. Vacuum dissipation canoccur at any rate required by a particular application, as indicated forillustrative purposes by the slope of line DE, such as until the vacuumhas fully dissipated, as illustrated by reference E in FIG. 15G.

As described above, lancing can occur at any time during a vacuum cycle,including before, during, or after a vacuum is created, and canadvantageously occur when at least a partial vacuum is created, such asbetween 30% and 70%, or any increment there between, of the maximumvacuum for a particular application. In at least one embodiment, whichis but one of many, lancing can advantageously occur at between 40% and60% of vacuum creation, or any increment there between, such as at 50%vacuum creation. For example, the maximum vacuum can be −20 inHg, andthe surface can be lanced when the vacuum in vacuum chamber 154 is, forexample, −10 inHg. However, this need not be the case, and the examplesdescribed herein are for illustrative purposes. The timing of lancingcan, but need not, be adjustable. For example, in at least oneembodiment, such as a commercial embodiment, which is but one of many,system 500 can include a plurality of interchangeable lancing shafts,each of which can have a different length, which can determine whenlancing occurs during a vacuum cycle, as described above.

FIG. 16 is an isometric schematic view of yet another of manyembodiments of a vacuum lance system 500 according to the disclosure.FIG. 17 is an isometric assembly schematic view of the vacuum lancesystem 500 of FIG. 16. FIGS. 16-17 will be described in conjunction withone another. FIGS. 16-17 illustrate yet another of many embodiments ofsystem 500, which can include a lancing mechanism 518, vacuum mechanism532, and release mechanism 542, such as one or more of those describedherein, separately or in combination, in whole or in part. Thisembodiment can generally function similarly to one or more of the othersystem embodiments described herein, as will be understood by a personof ordinary skill in the art having the benefits of the presentdisclosure, and like features and methods may not be described againhere in order to avoid repetition.

As with one or more of the other embodiments shown and described in thepresent disclosure, the vacuum lance system 500 of FIGS. 16-17 caninclude a device body 102, which can include one or more end caps 108,110, coupled thereto or formed integrally therewith, in whole or inpart. Body 102 can, but need not, be at least partially curved orcontoured, such as on its exterior, for providing a comfortable,ergonomic, or user-friendly grip as required by a particularapplication. A lancing mechanism 518 can be coupled to body 102, such asto lancing end 104, for supporting a lance 120 (also known as a“lancet”). Lancing mechanism 518 can include a lancing shaft 122slideably coupled with end cap 108, such as along central longitudinalaxis X, for communicating lance 120 with a surface during lancing.Lancing shaft 122 can include a bottom lance coupling end 124 and a topactuating end 126. Lancing mechanism 518 can include a lance coupler 128coupled to lance coupling end 124 for coupling lance 120 to shaft 122,removably or otherwise. Lancing mechanism 518 can include one or morebiasing devices, such as lancing springs 130 a, 130 b (collectivelyreferred to as lancing spring 130). Lancing spring 130 can be coupled tolancing shaft 122 for biasing shaft 122 in one or more directions,temporarily, momentarily or otherwise, as further described above.

System 500 can include a release mechanism 542, such as a firingassembly, which can include a release 144, one or more release couplers,and one or more components coupled there between. As shown for exemplarypurposes in FIGS. 16-17, system 500 can advantageously include theembodiment of release mechanism 542 shown in FIGS. 14C, 14D anddescribed above, separately or in combination with one or more of theother exemplary release mechanisms described herein, in whole or inpart. Release mechanism 542 can include structure for cooperating withother components of system 500, such as lancing mechanism 518, vacuummechanism 532, or other elements of the system, separately or incombination. For example, release mechanism 542 can be adapted tocooperate with main shaft 134, such as by including one or more releasecouplers 141, for example, to optionally couple with release coupler140, piston 148, and/or other system components coupled to shaft 134, toreleasably hold main shaft 134 in one or more positions. In at least oneembodiment, release 144 can sealingly engage one or more portions of thesystem, such as body 102 or end cap 108, which can, but need not includeone or more couplers 702, such as an O-ring, gasket, washer, seal orother device for at least partially limiting the entrance or escape offluid, such as into or out of body 102 or vacuum chamber 154. System 500can include one or more shaft couplers, which can include one or moreportions, such as first portion 160 a and second portion 160 b, for atleast temporarily coupling together lancing shaft 122 and main shaft134. Shaft coupler 160, or a portion thereof, can be coupled to anothercomponent of the system, such as one of shafts, 122, 134, in any mannerrequired by a particular application, which can, but need not, includeuse of one or more fasteners 704, such as a pin, screw, bolt, shaft,adhesive, or other fastener, separately or in combination. System 500can include a knob 146 for cocking the system, which can, but need not,include two or more portions coupled to one another, such as firstportion 146 a, second portion 146 b and top end cap 110 (collectivelyreferred to as knob 146). As is also shown and described above (see,e.g., FIGS. 11-14D), vacuum mechanism 532 can include one or morecomponents for creating a vacuum in chamber 154, such as one or morevacuum springs 158 and pistons 148, which can, but need not, include oneor more O-rings 150.

With continuing reference to FIGS. 16-17, system 500 can include one ormore depth controllers 162, which advantageously can be at leastpartially formed from transparent material, for example, to include aviewing area 114, in whole or in part. Depth controller 162 can includeinterchangeable or modular units, which can include interchangeablespacers 164 for a particular depth controller 162. As another example,system 500 can include a plurality of interchangeable depth controllers,such as, for example, depth controller 162 and one, two, three or morealternative depth controllers 162. In either case, each interchangeablespacer 164 can, but need not, have a different calibrated length, suchas lengths L1, L2 and L3, which can include any length required by aparticular application. As another example, depth controller 162 can beadjustable, such as by way of one or more variable components, forexample, a spacer 164 of varying length or thickness, as will be furtherdescribed below. Typically, although not necessarily, the length of eachspacer 164 can be less than the length of a particular lance needle 120b to be used with the spacer. Each interchangeable unit can be graduatedand can, for example, vary incrementally from unit to unit. In at leastone embodiment, such as a commercial embodiment, system 500 can includeand be sold with a plurality of depth controllers as a set or kit. Auser can choose to use any of one or more depth controllers 162 requiredby a particular application, which can include choosing to use a depthcontroller already coupled to device body 102 or, as another example,can include choosing a depth controller separate from device body 102and coupling the chosen depth controller to device body 102. Similarly,system 500, or any set or kit including one or more components of system500, can include a plurality of interchangeable biasing devices, such asone or more interchangeable lancing springs 130 a, 130 b or vacuumsprings 158 for altering one or more lancing characteristics of thesystem. For example, each interchangeable biasing device can have one ormore unique characteristics, such as dimensional, material, orelasticity characteristics (e.g., spring constant). A particular biasingdevice, or combination of biasing devices, can be chosen and implementedas required by a particular application based on one or moreapplication-specific factors, such as the material or surface to belanced, the depth of lancing, required lancing or vacuum forces, orother factors, as will be readily understood by one of ordinary skillhaving the benefits of Applicant's disclosure.

FIG. 18 is a schematic view of one of many embodiments of a vacuum lancesystem 500 having an adjustable depth controller 162 in a first positionaccording to the disclosure. FIG. 19 is a schematic view of the system500 of FIG. 18 with the adjustable depth controller 162 in a secondposition. FIGS. 18 and 19 will be described in conjunction with oneanother. As described above, vacuum lance system 500 can include one ormore depth controllers 162 for controlling the depth of lancing, whichcan include one or more spacers 164 that can be interchanged, such asindividually or by way of interchangeable depth controllers 162 (see,e.g., FIG. 17). The general structure and function of one or more depthcontrollers 162 in accordance with the present invention have beendescribed above, for example, with respect to FIGS. 6-7C, and need notbe fully repeated. Turning to yet another of many embodiments of depthcontroller 162, system 500 can include an adjustable depth controller162 for controlling the depth of lance penetration, which can, but neednot, take the place of one or more of a plurality of interchangeabledepth controllers or spacers, and which can alternatively be used inconjunction therewith, in whole or in part. As shown in FIGS. 18-19,depth controller 162 can include adjustable structure, which can be anystructure required by a particular application, for varying thethickness “t” of spacer 164 over a range of values, such as between athickness for minimum penetration of surface 168 by lance needle 120 b,including no penetration, and a thickness for maximum penetration ofsurface 168. As described above, base 120 a can contact an upper surfaceof spacer 164 during lancing, which can limit the depth to which needle120 b can penetrate surface 168, such as to the difference betweenlength “l” of needle 120 b and the thickness “t” of spacer 164. As willbe understood by one of ordinary skill in the art having the benefits ofApplicant's disclosure, the value of thickness “t” can be maximized inorder to minimize, or even prevent, the depth of lance penetration, andthe value of thickness “t” can be minimized in order to maximize thedepth of lance penetration. For example, depth controller 162 can have a“safety” setting wherein the value of thickness “t” can be greater thanor equal to the value of length “l” of needle 120 b, thereby preventingneedle 120 b from protruding beyond spacer 164 when not intended, suchas during storage, travel or periods of non-use.

With continuing reference to FIGS. 18-19, one of many embodiments of anadjustable depth controller 162 can include an adjustable spacer 164 forvarying thickness “t”. For example, spacer 164 can include one or moreblocks 180 a, 180 b (collectively referred to herein as blocks 180),such as shims, wedges, disks, or other structure, for at leasttemporarily defining the adjustable thickness “t” of spacer 164. Forexample, at least one of the blocks, such as topmost block 180 a, can bemoveable, for example by rotating, sliding or other motion, separatelyor in combination, to change the relative positions of the blocks,thereby increasing or decreasing the overall thickness “t” of spacer164, such as by changing the distance between surfaces 181, 183 of theblocks. Alternatively, both blocks 180 can, but need not, be moveable.Blocks 180 can, but need not, be coupled to one another, and a moveableblock can cooperate with depth controller 162 in any manner required bya particular application, for example, by translating along a groove orother path, by friction fit or by rotating about or along a guidestructure, separately or in combination. In at least one embodiment of alancing system having an adjustable depth controller 162, which is butone of many, one or more blocks 180 can have a coupler 182 formanipulating the one or more blocks to adjust the thickness of spacer164. Coupler 182 can be any type of coupler required by a particularapplication, such as an opening, a protrusion, a threaded, grooved,notched or otherwise keyed hole (partial or thru), or other structure.Alternatively, coupler 182 can be absent. Coupler 182 can, but need not,be adapted to couple or otherwise cooperate with one or more actuators184 for moving one or more blocks 180 between one or more positions toat least temporarily define or “set” the thickness of spacer 164.Actuator 184 can be any type of actuator required by a particularapplication, such as a rod, lever or other structure, and can be coupledto coupler 182 temporarily, permanently, or otherwise, including beingformed integrally therewith, in whole or in part. As another example,actuator 184 can be a user-supplied actuator, such as a user's fingertipor another device for moving a block 180, for example, a bobby pin,toothpick, the head of a pen or pencil, or another device. As will bereadily understood by one of ordinary skill having the benefits ofApplicant's disclosure, adjustable depth controller 162 or spacer 164can be adjustable in any one or more of many conventional manners ofadjustment, separately or in combination, and the adjustable componentsof system 500 shown in FIGS. 18-19 are but a few of many possibilities.For example, adjustable depth controller 162 can have a spacer of fixeddimension, and the distance between the spacer and the system body canbe adjustable, such as by way of sliding, threaded, or otherwisemoveable features. As will also be understood by one of skill in theart, although adjustable depth controller 162 is described herein withreference to system 500 for illustrative purposes, the characteristicsand components of these elements apply equally to all other lancingsystems described herein, separately or in combination, specificallyincluding, without limitation, systems 100, 300 and 400 described withreference to FIGS. 1-10.

Other and further embodiments utilizing one or more aspects of theinvention described above can be devised without departing from thespirit of Applicant's invention. Further, the various methods andembodiments of the lancing system can be included in combination witheach other to produce variations of the disclosed methods andembodiments. For example, unless the context requires otherwise, all ofthe elements and methods described with reference to the embodiments ofFIGS. 1-10 apply equally to the embodiments of FIGS. 11-19, andvice-versa. Discussion of singular elements can include plural elementsand vice-versa. References to at least one item followed by a referenceto the item may include one or more items. Also, various aspects of theembodiments could be used in conjunction with each other to accomplishthe understood goals of the disclosure. Unless the context requiresotherwise, the word “comprise” or variations such as “comprises” or“comprising,” should be understood to imply the inclusion of at leastthe stated element or step or group of elements or steps or equivalentsthereof, and not the exclusion of a greater numerical quantity or anyother element or step or group of elements or steps or equivalentsthereof. The device or system may be used in a number of directions andorientations. The order of steps can occur in a variety of sequencesunless otherwise specifically limited. The various steps describedherein can be combined with other steps, interlineated with the statedsteps, and/or split into multiple steps. Similarly, elements have beendescribed functionally and can be embodied as separate components or canbe combined into components having multiple functions.

The invention has been described in the context of preferred and otherembodiments and not every embodiment of the invention has beendescribed. Obvious modifications and alterations to the describedembodiments are available to those of ordinary skill in the art. Thedisclosed and undisclosed embodiments are not intended to limit orrestrict the scope or applicability of the invention conceived of by theApplicant, but rather, in conformity with the patent laws, Applicantintends to fully protect all such modifications and improvements thatcome within the scope or range of equivalent of the following claims.

What is claimed is:
 1. A vacuum assisted lancing system for bloodextraction, comprising: a tubular body having a central longitudinalaxis, a lancing end and a free end; a lancing mechanism coupled with thebody and configured to removably couple with a lance; a vacuum mechanismcoupled with the body and including a piston slideably coupled withinthe body so that a vacuum chamber is formed between the piston and thelancing end of the body; a release mechanism configured to selectivelyhold the vacuum mechanism in an energized state; and an opening throughthe body between the piston and the lancing end of the body that allowsfluid communication between the vacuum chamber and an atmospheresurrounding the vacuum chamber.
 2. The lancing system of claim 1,wherein the opening is configured to be sealingly engaged by a user sothat the user can selectively block and unblock the opening.
 3. Thelancing system of claim 1, wherein the release mechanism furthercomprises a release, and wherein the opening is disposed in the release.4. The lancing system of claim 3, wherein the release has an activatedposition, and wherein the opening is configured to be at least partiallyblocked when the release is in the activated position.
 5. The lancingsystem of claim 1, further comprising a valve coupled to the opening. 6.The lancing system of claim 1, further comprising a tubular lance guidehaving one end removably coupled to the lancing end of the body and alongitudinally opposite end configured to sealingly engage a surface tobe lanced, the lance guide having a transparent viewing area.
 7. Thelancing system of claim 1, further comprising a depth controller havingone end removably coupled to the lancing end of the body and alongitudinally opposite end configured to sealingly engage a surface tobe lanced.
 8. The lancing system of claim 7, wherein the depthcontroller is adjustable.
 9. The lancing system of claim 7, wherein thedepth controller further comprises a spacer having a variable thickness.10. The lancing system of claim 1, further comprising a lance coupled tothe lancing mechanism.
 11. A vacuum assisted lancing system for bloodextraction, comprising: a body having a first end adapted to sealinglyengage a surface to be lanced, a longitudinally opposite second end, anda vacuum chamber between the first and second ends; means for creating avacuum in the vacuum chamber and acting on the surface; means fordisposing a lance in contact with the surface while the vacuum is actingon the surface; and means for selectively commencing dissipation of thevacuum after the vacuum has acted on the surface for a period of time,wherein the means for selectively commencing dissipation of the vacuumincludes an opening through the body that allows fluid communicationbetween the vacuum chamber and an atmosphere surrounding the vacuumchamber.
 12. The lancing system of claim 11, wherein the means forcreating a vacuum further comprises a release coupled to the body, andwherein the opening through the body is disposed through the release.13. The lancing system of claim 11, further comprising means forsimultaneously initiating creation of the vacuum and at least partiallyblocking the opening through the body.
 14. The lancing system of claim11, further comprising means for dissipating the vacuum at a controlledrate.
 15. The lancing system of claim 11, further comprising a lancecoupled to the means for disposing a lance in contact with the surface.16. A method of manipulating a surface for blood extraction with avacuum assisted lancing system including a tubular body, a lancingmechanism coupled with the body and having a lance coupler configured toremovably couple with a lance, a vacuum mechanism including a pistonslideably coupled within the body so that a vacuum chamber is formedbetween the piston and a lancing end of the body, a release mechanismconfigured to selectively hold the vacuum mechanism in an energizedstate, and an opening through the body between the piston and thelancing end of the body that allows fluid communication between thevacuum chamber and an atmosphere surrounding the vacuum chamber, themethod comprising: coupling the lancing system to the surface; blockingthe opening; activating the lancing system, thereby creating a vacuum,subjecting the surface to the vacuum, and moving the lance coupler froma first position distal from the surface to a second position proximalto the surface; maintaining the vacuum for a period of time; andcommencing dissipation of the vacuum by unblocking the opening, therebyallowing the surface to fluidicly communicate with an atmospheresurrounding the lancing system while the lancing system is coupled tothe surface.
 17. The method of claim 16, wherein the lancing systemincludes a release coupled with the opening, and wherein the blockingand activating steps are accomplished simultaneously by engaging andholding the release.
 18. The method of claim 17, wherein commencingdissipation of the vacuum further comprises disengaging the release. 19.The method of claim 16, wherein blocking the opening further comprisessealingly engaging the opening with a finger, and wherein unblocking theopening further comprises disengaging the opening and the finger. 20.The method of claim 16, wherein the lancing system includes a lanceremovably coupled to the lance coupler, and wherein the method furthercomprises lancing the surface.